NDC 61919-565 Ondansetron

Ondansetron

NDC Product Code 61919-565

NDC Code: 61919-565

Proprietary Name: Ondansetron What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ondansetron What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)
Shape: OVAL (C48345)
Size(s):
6 MM
Imprint(s):
F;91
Score: 1

NDC Code Structure

NDC 61919-565-10

Package Description: 1 TABLET, FILM COATED in 1 BOTTLE

NDC 61919-565-12

Package Description: 12 TABLET, FILM COATED in 1 BOTTLE

NDC 61919-565-20

Package Description: 20 TABLET, FILM COATED in 1 BOTTLE

NDC 61919-565-30

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC 61919-565-90

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Ondansetron with NDC 61919-565 is a a human prescription drug product labeled by Direct Rx. The generic name of Ondansetron is ondansetron. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Direct Rx

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ondansetron Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ONDANSETRON HYDROCHLORIDE 4 mg/1
  • ONDANSETRON HYDROCHLORIDE 4 mg/1
  • ONDANSETRON HYDROCHLORIDE 4 mg/1
  • ONDANSETRON HYDROCHLORIDE 4 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
  • TRIACETIN (UNII: XHX3C3X673)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Serotonin 3 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Serotonin-3 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Serotonin 3 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Serotonin-3 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Serotonin 3 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Serotonin-3 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Serotonin 3 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Serotonin-3 Receptor Antagonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Direct Rx
Labeler Code: 61919
FDA Application Number: ANDA078539 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-23-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Ondansetron

Ondansetron is pronounced as (on dan' se tron)

Why is ondansetron medication prescribed?
Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron is in a class of medications called serotoni...
[Read More]

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Ondansetron Product Label Images

Ondansetron Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Indications And Usage

  • Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy.Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.

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